cannabinol use in patients with insomnia disorder

Conditions: Insomnia Disorder

Summary: this study aims to investigate the acute effects of cannabinol (cbn) 30 mg and 300 mg, versus placebo, on sleep architecture and next-day functioning in adults aged 25-65 years with chronic insomnia disorder.

this is a randomised, double-blind, placebo-controlled, three-arm, crossover, single-centre, proof-of-concept study in twenty participants with chronic insomnia disorder (as per clinician diagnosis and insomnia severity index \[isi\] score ≥15). across three overnight treatment sessions, participants will receive single dose oral liquid 30 mg cannabinol (cbn), 300 mg cbn, and matched placebo. participants will undergo overnight sleep assessment using in-laboratory polysomnography (psg) to examine cbn-related changes to sleep parameters; and various objective and subjective measures of sleep and next-day neurobehavioral function. each treatment session will be separated by the two-week washout period.

Eligibility criteria:
inclusion criteria: 1. between 25 - 65 years of age 2. insomnia severity index (isi) score ≥ 15 at eligibility screening 3. insomnia disorder (symptoms occurring at least 3 times per week and present for longer than 3 months) as determined by the study physician 4. ability to take oral medication 5. provision of signed and dated informed consent form 6. stated willingness to comply with all study procedures and availability for the duration of the study exclusion criteria: 1. medical condition or medication that is the cause of the insomnia disorder as determined by the study physician 2. known hypersensitivity to cannabis or cannabinoid products (including if this becomes evident during the trial) 3. reported use of cannabis or cannabinoid products within the past 3 months as confirmed by at least one negative urine drug screen (uds) (or at the study physician's discretion) 4. sleep apnoea (defined as apnoea hypopnea index \[ahi\] \> 15 and oxygen desaturation index \[odi\]\>10) as confirmed by polysomnography at screening 5. sleep-related movement disorder as determined by the study physician 6. delayed or advanced sleep phase syndrome (based on actigraphy and sleep diary) as confirmed during screening 7. any medical condition that produces an abnormal eeg (i.e., epilepsy, brain injury) 8. clinically relevant cardiovascular abnormalities as determined by the study physician and a 12-lead electrocardiogram (ecg) at screening 9. shift work or trans meridian travel (two time zones) within the last month 10. history of major psychiatric disorder in the past 12 months at the study physician's discretion, except clinically managed mild depression and/or anxiety 11. history of suicide attempt or current suicide ideation (score greater than 1 on q9 of the patient health questionnaire \[phq-9\]) 12. pregnancy or lactating. female participants are required to complete a urine pregnancy test at screening and treatment sessions and all participants are instructed to use a reliable form of contraception throughout the study duration 13. history of drug or alcohol dependency or abuse within approximately the past 2 years 14. use of cns-active drugs (cannabis, amphetamines, cocaine, antidepressants, opioids, benzodiazepines) in the past 3 months as confirmed by a positive urine drug test at screening or at the study physician's discretion 15. use of medications that may have a clinically significant impact upon the metabolism and excretion of cannabinoids as determined by the study physician (e.g., cyp450 enzyme inducers/inhibitors 16. excessive caffeine use that in the opinion of the study physician contributes to the participant's insomnia disorder, or the inability to abstain from caffeine use 24 hours prior to each overnight sleep study 17. inability to refrain from alcohol consumption 24 hours prior to each overnight sleep study 18. individuals with nicotine dependence (i.e., daily smokers) 19. medical conditions that result in frequent need to get out of bed (e.g., sleep walking, nocturia) 20. psychological or behavioural treatment for insomnia disorder, including cognitive behavioural therapy for insomnia, within 3 months before screening (excluding sleep hygiene advice) 21. occupational or judicially ordered drug screening 22. has held an unrestricted driving license \< 1 year 23. cannot speak english fluently

Keywords: cannabinol cbn cannabinoid medicinal cannabis primary insomnia chronic insomnia disorder sleep architecture wake after sleep onset polysomnography next-day function randomised controlled trial placebo-controlled crossover double-blinded